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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system,test,antibodies,b2 - glycoprotein i (b2 - gpi)
510(k) Number K982879
Device Name SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
Applicant
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Applicant Contact EILEEN A MCCAFFERTY
Correspondent
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Correspondent Contact EILEEN A MCCAFFERTY
Regulation Number866.5660
Classification Product Code
MSV  
Date Received08/14/1998
Decision Date 10/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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